REGULATORY UPDATE

REGULATORY UPDATE

About six months months ago rumours begun to trickle through to the natural health sector that the Medicines Control Council were realizing that the November 2013 Complementary Medicines regulations were unimplementable for various reasons.

We heard the Medicines Control Council were looking abroad for a system that would (a) be less human-resource dependent, and (b) allow for the fast-tracking of applications for the majority of Complementary Medicines. In the few rare meetings held between the industry and the MCC, the MCC revealed that the five-year Road Map for the phased registration for Complementarty Medicines had also become problematic.

The TNHA has already fleshed out many of the flaws in the existing Complementary Medicine regulations and the process leading up to them being passed, with the most pressing issue being the lack of transparency in the Department of Health’s drafting of regulations, and zero engagement with stakeholders.Still to this day, representative stakeholder groups have been unable to engage directly with the MCC on issues related to natural health product regulations.

There is also no feedback or engagement with those drafting the amendments currently being worked on. Now we hear that Canada’s Natural Health Product licensing scheme is being considered as a Plan B for implementation in South Africa.

WHY HAS IMPLEMENTATION FAILED?

The current regulations for natural health products are hugely problematic, not only for industry, but for the regulator as well. Many companies have not submitted applications for registration, for various reasons. The MCC received only fifteen applications when they expected hundreds in the first Road Map call-up.

One reason must be that the regulatory environment is so confusing: amendments to regulations are issued, new quality, safety and efficacy guidelines are issued, the definition of ‘Complementary Medicine’ has changed four times, and compliance is so difficult that well-paid consultants cannot even predict with certainty whether products will be registered or not. Even the legality of the regulations is in question.

Many have adopted a ‘wait-and-see’ attitude while the powers-that-be come up with a plan that is hopefully fair, affordable and easy to implement. Many companies have not complied with the mandatory labeling of their products with a disclaimer stating they have not been assesed by the MCC. Others have continued to make ‘unapproved’ health claims regardless.

The regulators’ response has been to look abroad.

It’s unclear exactly who is involved in drawing up regulations, but it seems that the Department of Health draws on the MCC and other advisors to do the job.

We would like to know who these people are, and whether there is a fair representation of people who understand the difference between drugs and natural products, their risks and the way they are used.

We know that in April this year a delegation of DoH (icluding MCC) officials traveled to Canada and met with Health Canada officials to review and assess the Canadian regulatory system, which is controlled by the Natural and Non-prescription Health Products Directorate (NNHPD). We have learned that they decided on their return to emulate the Canadian system.

This will now form part of significant amendments to the current ‘Complementary Medicines’ regulations, expected to be published later this month or ealy next month. We are aware that most of the work on drafting the new amendments to regulations has been done, and that the QSE documents for ‘Complementary Medicine’ and ‘Health Supplements’ are in an advanced stage of drafting.

LACK OF TRANSPARENCY AND ENGAGEMENT

But where is the transparency and consultation? Surely after the huge public and industry outcry, consultation with those affected would be a priority?

Not at all. Since April the MCC and it’s expert Complementary Medicines Committee have failed to engage with the natural health product sector in the drafting of the amendments, despite, it is rumored, significant alterations to the registration procedures, and expanding the definition of ‘Complementary Medicines’. We have been informed by reliable sources that the upcoming regulatory amendments will be gazetted and implementable with immediate effect, and that no comment period will be afforded to industry and citizens.

This is all too familiar to us: Almost two years ago, in November 2013, the current Complementary Medicine regulations were issued without time to comment on them in draft form. In other words, the future of the thriving natural health products industry, and the health of our citizens, was determined behind closed doors by a group of nameless bureaucrats. Is this transparency?

This runs counter to the participles of good governance, administrative justice and the very cornerstone of our democracy, which predicates that all laws must be made from the bottom up (with consultation), and not from the top down (autocracy). This is legislation by regulation, and in our opinion, unconstitutional.

WHAT HAPPENED IN CANADA?

The only advantage of the Canadian regulatory system for natural health products is slightly more expedited system, where established, registered pharmaceutical companies with GMP certification can design and register low-potency multi-vitamins and minerals, single ingredient herbal products and a peppering of pre-approved multi-inredient products based on long established (no evidence-based) formulae found in a traditional medicine reference books, dating back 75 years and older. The expedited system is driven by pre-approved monographs, with pre-approved health claims and maximum daily dosages.

In other words, the system will allow for the least efficacious products to gain registration with ease, while the balance of innovative, multi-ingredient products will find it almost impossible and prohibitively expensive to register for reasons mentioned below.

In 2004, Canada had 75 000 natural health products on the market. In the seven years after their new system was introduced, +/- 20 000 of those existing products were removed from the market, due to small and medium sized companies being unable to comply with the pre-authorization requirements. 14 000 product applications were rejected outright, often without any scientific or risk-based rationale.

The bulk of products which remain on the market in Canada have either been reformulated out of efficacy (potencies lowered and ingredients removed/substituted), or form part of a glut of cheap, drug-company produced multivites. Well-established foreign companies and those from the USA have all but stopped trading in Canada. When the new “improved” regulatory framework for Complementary Medicine and Health Supplements is announced, it will no doubt be hailed as the result of genuinely ‘listening’ to the concerns of the industry, which will be nothing more than a blatant lie. All MCC workshops advertised and attended thus far have been lectures of what is prescribed, and no adequate question time or debate has been allowed.

What they won’t reveal is that the Canadian system is far from perfect and there is as much “devil in the detail” in it as in our current regulatory system. For pharmaceutical companies who don’t want to see a dent in their low-potency multivitamin product sales, and threatened by competing, non-drug therapeutic products, the Canadian-styled system will be welcomed: It will remove competition of quality, innovative products, and expand their market share. They will no doubt support the new regulations.

For the manufacturers and importers of innovative natural health products, there will be little relief, it seems. Health stores which set themselves apart from discount pharmacy chains and supermarkets by stocking specialist products will struggle to fill their shelves.

Practitioners will be forced to invest in a fully stocked dispensary and/or compound their medicines from scratch. Practitioner-only products, indispensable to integrative doctors, will not be available because the regulations do not discriminate on whether a product is for open sale or not. If it falls within the definition of a Complementary Medicine, it’s a medicine, ie, it is comprised of certain substances, makes a health claim and is in medicine dosage form.

The Canadian system is not only earmarked for South African adoption, but for the United Kingdom as well. At a recent inter-regulatory body meeting in Europe it was announced that both South Africa and the UK will be using the Canadian system as a benchmark for their domestic regulations. We believe this will set a precedent for other countries in later years. For this reason, the TNHA has forged links with Canadian and UK-based organizations similar to our organization, who are prepared to work together to stop this system from taking root here in South Africa.

In Canada, an organization called Citizens for Choice in Healthcare are challenging the Canadian regulations for natural health products in their Federal Court of Appeal, based on key constitutional issues. The Alliance for Natural Health in the UK, with whom we are now collaborating is monitoring and assessing what has transpired in Canada, and what’s going to be revealed in South Africa in the coming months and will respond accordingly. The Alliance for Natural Health have been effective in the past, in challenging oppressive EU Directives against natural health products in the European Court of Justice.

In the coming months, we will be contacting you to join one of our stakeholder working groups, which will drive our organization’s monitoring and lobbying activities. The TNHA will be expanding its membership and reach, and each sector will appoint its own steering committee to represent their interests.